Performance Comparison of Two Sysmex Hematology Analyzers: The XN-550 and The XS-1000i
Performance Comparison of Two Sysmex Hematology Analyzers: The XN-550 and The XS-1000i
1 (2018)
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Comprised of three main instruments, the XN-L Series instruments include an embedded IPU (information
offerings differ primarily in automation features and tube processing unit) with touchscreen display.
handling capabilities. Samples can be run by manual The XN-L Series may serve as a replacement for the XS-
analysis, which requires the medical laboratory scientist 1000i, the Sysmex legacy analyzer. Compared with this
to physically hold a single sample up to the aspiration analyzer, the XN-L Series offers the following
sensor or place it in the analyzer for testing; or by improvements and features including additional
sampler analysis, which involves loading multiple sample parameters and testing modes, onboard rules, and
tubes into a testing rack which then automatically increased storage capability (Table 2). Upon comparison
approach the aspiration sensor for analysis. The of the two instruments notable channel improvements for
Automated Hematology Analyzer XN-350 (XN-350; the XN-L Series include the addition of a reticulocyte
Sysmex Corporation, Kobe, Japan) accommodates (RET) detection channel and an enhanced WDF channel
manual analysis with open-tube sampling, while The for differential counting.
Automated Hematology Analyzer XN-450 (XN-450;
Sysmex Corporation, Kobe, Japan) also uses single Table 3 summarizes key features between the XN, XN-L
sample analysis and, in addition, offers both open-tube and XS-1000i Series of instruments. The XN-L offers
sampling and cap-piercing closed sampling functions. enhanced nRBC flagging compared to the XS-1000i
The largest and most fully equipped XN-550 comes Series as well as many of the same features as the XN-
standard with a continuous-feed autoloader and features Series.
automated repeat/rerun/reflex capability. All three
Table 3 Feature comparison between XN, XN-L, and XS-1000i Series analyzers
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Table 4 lists sample volume requirements for whole Table 5 summarizes sample throughput for whole blood,
blood, pre-diluted blood, and body fluids 8). Depending low WBC samples, pre-diluted blood, and body fluids.
on the collection tube chosen, sample volume Depending on the tests run, sample throughput of up to
requirements can be as low as 250 µL for the sampler 60 samples per hour is possible.
mode or 100 µL (WB), 140 µL (PD or BF) for manual
analysis. (Table adapted from Hamaguchi Y, Kondo T, Nakai R,
Ochi Y, Okazaki T, Uchihashi K, Morikawa T.
(Table adapted from Hamaguchi Y, Kondo T, Nakai R, Introduction of Products: Overview and Features of the
Ochi Y, Okazaki T, Uchihashi K, Morikawa T. Automated Hematology Analyzer XN-L Series. Sysmex
Introduction of Products: Overview and Features of the Journal International. 2015;25(1))
Automated Hematology Analyzer XN-L Series. Sysmex
Journal International. 2015;25(1))
Required Aspirated
Analysis method Specimen Test tube Cap sample sample
volume volume
Sampler analysis Whole blood Regular sample tube Closed 1 mL 25 µL
Raised bottom tube
(RBT) micro collection Closed 250 µL
tube
Manual analysis Whole blood Regular sample tube Closed 1 mL 25 µL
Open 300 µL
RBT micro collection tube Closed 250 µL
Micro collection tube Open 100 µL
Diluted blood Regular sample tube Open 300 µL 70 µL1
Micro collection tube Open 140 µL
Body fluid 2 Regular sample tube Closed 1 mL 70 µL
Open 300 µL
Micro collection tube Closed 140 µL
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2. Testing criteria
MATERIALS AND METHODS 1) Correlation between the Sysmex XN-550 and the XS-
1000i analyzers
The instrument performance evaluation comparing the Between 175 and 195 residual whole blood samples were
Sysmex XN-550 with the Sysmex XS-1000i was analyzed using all analysis modes on XN-550. The
conducted at TriCore Reference Laboratories, variation in sample size was due to instrument-excluded
Albuquerque, NM. samples and those excluded manually due to insufficient
sample quantity or inadequate mixing.
Standard practice protocols and statistical analysis were The same samples were also run on the XS-1000i and
used to evaluate the analyzers in the following areas: correlation coefficients were calculated using EP
1. Correlation between the Sysmex XN-550 and the XS- Evaluator software (Data Innovations LLC).
1000i analyzers
2. Linearity of the XN-550 results Statistical Analysis
3. Precision/repeatability of the XN-550 using both pre- For each of the following tests listed in the table below,
dilute and whole blood samples sample data was displayed in Passing-Bablok 9) (scatter
plots) along with overlaid regression lines. In addition,
Both instruments were set up in accordance with industry regression statistics were presented.
standards and manufacturer recommendations.
2) Linearity of the XN-550
The linearity of a hematology instrument can be verified
1. Sample preparation by comparing the laboratory's reportable range with
The study was performed using human peripheral whole commercially available linearity assays. RANGE
blood samples collected in K2 EDTA. CHECK™ III and RET-CHECK™ II for reticulocytes
were used to verify the linearity of the XN-550
Abnormal samples were expected to represent various throughout its full range.
clinical conditions of platelet, white cell, and red cell
dysfunction. Special consideration was given to nRBCs, 3) Precision/repeatability of the XN-550 using both pre-
low platelets and immature or abnormal WBCs (i.e., dilute and whole blood samples
blasts, bands, immature granulocytes, variant Nine normal whole blood samples from healthy
lymphocytes) as well as RBC abnormalities (i.e., individuals were analyzed in series ten times on the
fragments, inclusions, or hemoglobinopathies). XN-550. Sample analysis was performed within four
hours of blood collection. The CV% and SD were
Samples were considered normal/negative if they met the calculated.
following criteria: The same nine samples were diluted (1:7) and analyzed
a) No clinical evidence of medical disorder known to ten consecutive times in the pre-dilute mode on the XN-
affect WBC or differential count 550. Sample analysis was completed within five hours of
b) CBC parameters within normal range blood collection. The CV% and SD were also calculated
c) Normal serum chemistry values (if available) and compared to data from the whole blood mode.
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White blood cells, WBC (10 3/µL) Red blood cells, RBC (10 6/µL)
Scatter Scatter
y=0.976x+0.0305 y=1.015x-0.0031
r=0.9998 r=0.9958
n=195 n=195
XN-550
XN-550
XS-1000i ..........Deming regression XS-1000i ..........Deming regression
XN-550
Mean corpuscular volume, MCV (fL) Mean corpuscular hemoglobin, MCH (pg/cell)
Scatter Scatter
y=0.954x+2.62 y=1.001x-0.04
r=0.9920 r=0.9920
n=195 n=195
XN-550
XN-550
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XN-550
XS-1000i ..........Deming regression XS-1000i ..........Deming regression
XN-550
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XN-550
XS-1000i ..........Deming regression XS-1000i ..........Deming regression
XN-550
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XN-550
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The same nine blood samples were then diluted (in a 1:7
2. Linearity of the XN-550 ratio) and processed again through the analyzer ten times
Table 7 lists the manufacturer's reported range and the using pre-dilute mode.
range reported by the study site for WBC, RBC, HGB,
HCT, PLT, and RET. The mean, standard deviation, and coefficient of
variation were computed and compared for both modes.
Graphs of linearity demonstrated that actual values Fig. 1 charts the mean CV% of the nine samples (i.e.,
tracked expected values closely for WBC, RBC, HGB, Sample 1 CV% + Sample 2 CV% + .... + Sample 9 CV%
HCT, PLT, and RET. A coefficient of determination for divided by 9).
all tests ranged between 0.999 and 1.000 for
manufacturer-established linearity. The figure below shows the mean CV% plotted against
all the blood components for both pre-diluted and for
whole blood.
3. Precision/repeatability of the XN-550 using
both pre-dilute and whole blood samples of all Fig. 1: Mean CV% of nine samples each of PD(Pre-
parameters from all channels Dilute) and WB(Whole Blood)
To determine repeatability, nine whole blood samples
were processed through the XN-550 analyzer ten times
each.
Sysmex TriCore
Low High Low High
WBC, 10 3/µL 0 440 0 556.01
RBC, 10 6/µL 0 8.60 0 8.42
HGB, g/dL 0 26.0 0 27.5
HCT, % 0 75.0 0 74.2
PLT, 10 3/µL 0 5,000 0 5,681.5
RET, % 0 30.0 0 22.35
Fig. 1 Mean CV% of nine samples each of PD (Pre-Dilute) and WB (Whole Blood)
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There was high correlation of results (r > 0.90) for most In urgent care settings the small footprint and high
parameters between the new XN-550 and the legacy throughput are beneficial when space and time are
analyzer XS-1000i. Lower correlations were seen for limited. Also the XN-L Series offers the automated
MCHC, BASO%, and MONO#. Immature Granulocyte (IG) which may be an indication
of infection or inflammation. Body fluid analysis (BF
Correlation for mean cell hemoglobin content (MCHC) mode) is available for use with cerebrospinal, serous and
presented with a lower value than the other parameters at synovial fluids which may reduce the need for more time
r = 0.8935, possibly due to a narrow distribution of consuming manual laboratory methods. The BF mode
sample data in the middle of the range of values skewing offers a total cell count, WBC, RBC, and a two-part
the regression curve. Bias was low, however, at 1.7%, differential for standardized body fluid analysis.
and the data points appeared generally in line.
Physician office laboratories handling family practice,
Similarly, the relative basophil count (BASO%) internal medicine and pediatric patients have opportunity
presented with a lower regression, r = 0.7885 and a bias with the XN-L Series analyzers. Accurate results make
of -13.4%. This may be explained given that basophils this system a must for routine health screening and the
are far fewer in number relative to the other types of routine care of patients with chronic conditions. Pediatric
WBCs and this level of variability has been reported in populations can benefit from the low sample aspiration
other studies 4). The BASO# also demonstrated a similar volume of 25 µL and the enhanced nRBC flagging
falloff at higher values, but the coefficient of correlation capabilities. By decreasing the amount of blood drawn
remained high (r = 0.9354). Bias was greater than most from these children the risk of phlebotomy-induced
of the other values as well at -21.1%. Most of the data anemia is reduced. As some estimates suggest that iron
points were below 1.5% and this tends to make the deficiency affects roughly ten percent of the pediatric
regression line more sensitive to smaller changes than if population, the RET-H e parameter (Reticulocyte
the data was distributed more evenly. The difference in Hemoglobin Equivalent) has been shown to be a
BASO% may be due to the improved discrimination of sensitive marker to detect iron deficiency before it
cell populations in the XN-550 WDF channel as progresses to anemia.
compared to the DIFF channel on XS-1000i.
In dialysis centers these analyzers can offer a
The blood component with the lowest correlation (r = comprehensive reticulocyte panel including IRF and
0.6449) was for the monocyte absolute count, MONO#. RET-He. Anemia is often a chronic concern in kidney
Bias was higher than the other components at -25.7%. patients since erythropoietin stimulates red cell
The difference in MONO# may be due to the improved production in the bone marrow and it is naturally
discrimination of cell populations in the XN-550 WDF produced in the kidney. The RET-H e parameter is a
channel as compared to the DIFF channel on XS-1000i. sensitive way to detect iron deficiency earlier in chronic
kidney disease patients. It may be more useful than
Results showed very high correlation (r2 > 0.999) in traditional iron studies as it is not affected by
linearity throughout the full range of the instruments inflammation or the acute phase response.
design with no anomalies observed.
For oncology patients who present with leukocytopenia
Precision/repeatability was acceptable for both pre- secondary to chemotherapy and treatment, the XN-L
diluted and whole blood samples. Coefficient of variation analyzer offers accurate white cell measurements using
was low for most blood components; however, basophils Low WBC mode. By increasing the analysis duration
(BASO#, BASO%) and immature granulocyte count three times longer, more cell events are counted ensuring
(IG#, IG%) showed a higher degree of variation, possibly a more precise measurement on these usually challenging
due to improved resolution of scattergrams and limited specimens. For fast-paced oncology centers the
availability of samples with high values. continuous sample loading and auto rerun/reflex of the
XN-550 accommodates a high volume throughput with
Flagging performance, evaluation of the low WBC mode, minimal technologist intervention, therefore allowing
and performance of the manual analysis sampling method timely result reporting of absolute neutrophil counts.
were outside the scope of this study and may be reported
on in the future.
CONCLUSION
The XN-L Series has wide applicability in many
diagnostic areas because of its advanced capabilities, The XN-L Series of hematology analyzers demonstrates
small size, ease of use and commonality to the larger XN a high degree of correlation with the legacy XS-1000i
Series analyzers. The XN-L is especially well suited for instrument, has acceptable linearity throughout its full
use in urgent care and free standing emergency rooms, range of detection, and provides a high degree of
family practice and pediatric clinics, dialysis centers and repeatability for both whole blood and pre-diluted blood.
oncology units. This series of hematology analyzers XN-L can provide standardized testing from Core Lab to
delivers solutions for laboratories and clinics that offer satellite labs, and affiliated Clinics and Physician Office
niche diagnostic testing. Dedicated functionalities Laboratories. Improved functionality of the XN-L Series
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Sysmex Journal International Vol.28 No.1 (2018)
analyzer over the XS-Series includes: a sampler with 3) Briggs C, Longair I, Kumar P, Singh D, Machin SJ. Performance
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